Safety Operations Adviser Specialist

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Søborg

Would you like to be a driving force in ensuring highest safety and lowest possible risk to patients that use Novo Nordisk products? Are you eager to be part of a team that leads and defines the direction for one of Denmark's most skilled and advanced safety functions? If so, you may be our new Safety Operation Adviser Specialist in Global Safety. Apply now for this exciting job-opportunity! The position As a Safety Operation Adviser Specialist, one of your main responsibilities will be to ensure the operational set-up of Real-World Clinical Studies. This includes assessing operational impact of new regulatory requirements, establish safety processes for new types of Real-world Study set-ups, facilitate decision making and drive initiatives for process improvement to secure regulatory compliance. Likewise, you will be responsible for evaluating individual safety cases received on development products used in clinical trials, considering knowledge about the safety profile of the trial product and potential impact of underlying conditions, diagnostic results, and differential diagnosis. You are also expected to bring in depth understanding of medical concepts and diseases when assuming responsibility for assessment of the potential risk to patients in relation to product quality issues and potential recall situations. Additional tasks and responsibilities include, but is not limited to:
  • Being a process expert when interacting with internal and external stakeholders.
  • Reviewing clinical trial and non-interventional study protocols to ensure collection of relevant safety information according to regulatory requirements and Novo Nordisk procedures.
  • Chairing cross functional groups on Clinical Trials/Non-interventional Studies, ensuring a forum where stakeholders from different skill areas within Global Safety can discuss safety relevant topics and ensure alignment in input from Global Safety to other areas within the Organization and external stakeholders.
    • Qualifications To excel in this role, we anticipate that you bring:
  • Master’s degree within Medicine, Pharmacy or equivalent medical and scientific background.
  • Clinical experience and a strong experience within pharmacovigilance, and preferably within Real World Clinical Studies.
  • A solid understanding of diagnostic processes, diagnostic techniques, and interpretation of diagnostic results.
  • The ability to evaluate impact and consequences of diseases and medical interventions.
  • Excellent communication skills and proficiency in English, both written and spoken.
    • On a personal level, you exhibit a collaborative nature and strong relationship-building skills, both with colleagues and external partners. You also demonstrate a strategic and proactive approach to tasks, consistently applying a pragmatic and solution-oriented mindset to your work. Your adaptability and strong sense of urgency make you an asset in fostering teamwork and thriving in diverse, multicultural environments. About the department Safety Operations is a department within Global Safety located in Søborg, Denmark. Global Safety is an organisation of more than 550 highly professional people with a background within natural science. The core activity and responsibility of Safety Operation Advisers is to perform medical assessment of serious adverse event reports on our medicinal products and evaluate the impact of potential product quality issues on patient safety, to ensure compliance with regulatory requirements globally. We offer a unique opportunity to work independently and in collaboration with a team of highly skilled, committed, and enthusiastic colleagues. A possibility to assume responsibility, communicate information and act in your daily work. You will have a close collaboration and interaction with other functional areas in Novo Nordisk and you will be an important contributor in the Novo Nordisk organisation. Working at Novo Nordisk Novo Nordisk is its people. We know that life is anything but linear, and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees. Together, we go further. Together, we’re life changing. Contact For further information, please contact Trine Schaffalitzky de Muckadell at +45 3077 7878. Deadline Sunday, 26 November 2023. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.


    Information og data

    Denne ledige stilling har jobtypen "Apoteker", og befinder sig i kategorien "Sundhed og forskning".

    Arbejdsstedet er beliggende i Søborg.

    Jobbet er oprettet på vores service den 10.11.2023, men kan have været deaktiveret og genaktiveret igen.

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    Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
    • Apoteker
    • Søborg
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